- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07716982
Estimation of Control Before and After Treatment of a Depressive Episode With Serotonin Reuptake Inhibitors (APTE-Sero)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The main questions it aims to answer are:
How do individuals with a depressive episode differ from healthy controls in their estimation of control over environmental events? How does antidepressant treatment (selective serotonin reuptake inhibitors) influence perceived control, cognitive performance, and depressive symptoms over time? Are changes in perceived control and symptoms associated with biological markers measured during the study?
Researchers will compare participants with a current depressive episode to healthy control participants, and examine changes over time in the depressed group before and after treatment initiation, in order to assess the effects of antidepressant treatment on cognition, perceived control, and symptoms.
Participants will:
- Complete 4 study sessions over approximately 8 weeks, including 2 in-person visits at the Centre de Recherche en Neurosciences de Lyon (CRNL) and 2 online sessions.
- Complete questionnaires assessing depressive symptoms, personality traits, and life events.
- Perform computerized behavioral tasks involving prediction, learning, memory, and decision-making in virtual environments.
- Complete tasks designed to assess perceived control over outcomes in different contexts.
- Undergo non-invasive physiological recordings during in-person sessions, including eye-tracking, heart rate monitoring, and muscle activity measurement.
- Perform short online versions of the cognitive tasks between visits.
- Healthy control participants will complete the same procedures, except for antidepressant treatment exposure, while the depressed group will be followed over time before and after treatment.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Romain Ligneul, PhD
- Número de teléfono: +33 04 72 13 89 00
- Correo electrónico: romain.ligneul@inserm.fr
Copia de seguridad de contactos de estudio
- Nombre: Méline Devaluez, PhD
- Número de teléfono: +33 04 37 91 55 14
Ubicaciones de estudio
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Bron, Francia, 69500
- Centre de Recherche en Neuroscience de Lyon
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Contacto:
- Romain Ligneul, PhD
- Número de teléfono: +33 04 72 13 89 00
- Correo electrónico: romain.ligneul@inserm.fr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria - applicable to all participants:
- Affiliated with a social security or national health insurance system, or entitled to such coverage.
- Male or female, aged 18 to 55 years.
- Fluent in spoken and written French.
- Normal or corrected-to-normal vision.
- Access to a computer and an internet connection.
- Available for the 8-week study period following treatment initiation (patients) or the baseline visit (healthy controls).
- Willing to use an effective method of contraception (condom, oral contraceptive pill, abstinence, or intrauterine device).
Additional inclusion criteria for the depressed patient group:
- Eligible for antidepressant monotherapy with a selective serotonin reuptake inhibitor (SSRI: sertraline, fluoxetine, citalopram, or paroxetine) or a serotonin-norepinephrine reuptake inhibitor (SNRI: venlafaxine or duloxetine), with or without concomitant treatment with a short half-life benzodiazepine (<12 hours; e.g., oxazepam, lorazepam, or clotiazepam), for which the prescription has been issued but treatment has not yet been initiated.
- Montgomery-Åsberg Depression Rating Scale (MADRS) score >6 and <35 (corresponding to mild-to-moderate depression), assessed during the routine clinical visit with the treating physician.
- No evidence of suicidal ideation, high-risk behaviors, history of suicide attempt, or overt psychotic symptoms that could compromise participant safety.
- No severe medical condition or unstable physiological state considered incompatible with study participation by the referring physician, including but not limited to unstable chronic diseases (e.g., hypertension or diabetes), respiratory insufficiency, cardiovascular insufficiency, or renal insufficiency.
Exclusion criteria applicable to all participants:
- History of a major depressive episode within the past 3 years.
- Use of antidepressants, mood stabilizers, or antipsychotic medication within the past 3 years.
- Diagnosis of a neurological or psychiatric disorder affecting central nervous system function (including bipolar disorder, schizophrenia, or other psychotic disorders according to DSM-5 criteria).
- Pregnancy or breastfeeding (self-reported).
- Individuals under legal protection (guardianship, curatorship, or judicial protection measures).
- Current participation in another interventional clinical trial or ongoing exclusion period following a previous clinical trial.
- Planned initiation during the study of a medication or substance known to interfere with serotonergic activity (including MDMA, LSD, psilocybin, ketamine, cocaine, 5-HT2A receptor antagonist antipsychotics, triptans, or lithium).
- Use of serotonin-acting recreational drugs within the previous 6 months (including cocaine, MDMA, or psychedelic substances).
- Refusal to be informed of the potential discovery of a clinically significant incidental finding.
Additional exclusion criteria for the depressed patient group
- Antidepressant treatment already initiated before study enrollment.
- Use of benzodiazepines within the 12 hours preceding an experimental session.
- Treatment with benzodiazepines other than oxazepam, lorazepam, or clotiazepam.
- Current hospitalization.
- Risk of suicidal behavior, defined as a score of ≥2 on the "zest for life" ("élan de vie") item of the Montgomery-Åsberg Depression Rating Scale (MADRS).
- Current treatment considered clinically incompatible with study participation by the physician responsible for recruitment.
Additional exclusion criteria for the healthy volunteer group :
Current or previous diagnosis of a depressive or anxiety disorder.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Depression group
Patients presenting a depressive episode and receiving serotonergic antidepressant treatment
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Participants are prescribed serotonergic antidepressants such as fluoxetine, sertraline, escitalopram, paroxetine, or serotonin-norepinephrine reuptake inhibitor (SNRI).
Dosage, formulation, frequency, and treatment duration are determined by the treating clinician.
No experimental manipulation of medication is performed within the study.
The intervention is characterized to assess its association with cognitive performance, reaction time (RT), accuracy, and controllability-related decision-making.
Experimental tasks assessing cognition, decision-making, and perceived controllability.
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Experimental: Control group
Healthy participants who are not receiving serotonergic antidepressant treatment.
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Experimental tasks assessing cognition, decision-making, and perceived controllability.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Controllability Estimation Bias in depressed patients
Periodo de tiempo: Change between baseline and week 8
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normalization of the controllability estimation bias in patients with depression after 8 weeks of treatment with a selective serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor (SNRI).
The assessment of controllability is not obtained directly from the participant, but through a computational model inferred from their behavioural data (reaction time (RT), prediction accuracy (percentage of correct responses) and error rate)
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Change between baseline and week 8
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Controllability Estimation Bias in Depressed Patients vs Healthy Controls
Periodo de tiempo: Baseline
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This measure compares the controllability estimation bias between participants with a current depressive episode and healthy controls using a behavioral task assessing perceived control over environmental outcomes
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Baseline
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Romain Ligneul, PhD, Institut National de la Santé Et de la Recherche Médicale, France
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Síntomas de comportamiento
- Comportamiento
- Depresión
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica.
- Agentes neurotransmisores
- Moduladores de transporte de membrana
- Inhibidores de la captación de neurotransmisores
- Agentes de serotonina
- Acciones farmacológicas
- Acciones y usos químicos
- Inhibidores selectivos de la recaptación de serotonina
Otros números de identificación del estudio
- 2026-A00663-48
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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